Mechanisms of Behavioral Activation (BA)

Multi-level Mechanisms of Behavioral Activation Therapy for Adolescent Depression

The investigators will be comparing brain (neural) activation of depressed adolescent patients before, during and after a course of Behavioral Activation (BA) therapy using functional magnetic resonance imaging (fMRI). In particular, the project seeks to determine whether BA targets different neural mechanisms for behavioral avoidance associated with low motivation as compared to threat avoidance. A group of healthy controls will also be scanned as a comparator group for behavioral and imaging measures.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Behavioral Activation Therapy; Behavioral: Baseline assessment procedures

Detailed Description

The primary aim of this study is to investigate the behavioral and neurobiological factors predicting response to Behavior Activation (BA), a psychosocial treatment for Major Depressive Disorder (MDD), in adolescents.

The recruitment age pool will be adolescents ages 15-17. The investigators plan to recruit 40 healthy controls and 96 treatment-seeking adolescents for an overall sample of ~136 participants, Individuals who reach the age of majority (18) during the study will be re-consented as adults and allowed to continue participating in the study.

A healthy control group will be included to assess stability in behavioral and neuroimaging measures over the course of participation in the study.

The fMRI scan schedule will include three task-based sessions (baseline, after session 7, and after endpoint) and two (sessions 3 & 9). "behavioral-scheduling-in-the-scanner" sessions Primary results will focus on symptom change within patients and their association to measures of low motivation and threat avoidance.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Treadway, PhD; Email: mtreadway@emory.edu
• Study Contact Backup: Name: Wade E Craighead, PhD; Phone Number: 4047273287; Email: ecraigh@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Contact: Wade E Craighead, PhD; Email: ecraigh@Emory.edu
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Facility for Education and Research in Neuroscience (FERN)
      • Contact: Michael Treadway, PhD; Email: mtreadway@emory.edu
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Child and Adolescent Mood Program (CAMP)
      • Contact: Wade E Craighead, PhD; Email: ecraigh@Emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and female adolescents ages 15-17;
• current MDD diagnosis as determined by K-SADS-PL,
• CDRS-R raw score > 45 (T-score > 65) at baseline;
• estimated full scale IQ > 80 as determined by the WASI-II;
• able to receive outpatient care;
• willing to not partake in other psychosocial treatments;
• not taking psychotropic medications in the two weeks (four weeks for fluoxetine) prior to consent, with the exception of psychostimulant medication prescribed for the treatment of ADHD.
• Additionally, depressed patients must have access to required technology (e.g. smart phone, tablet, or desktop computer) to complete the EMA portion of the study.
• Healthy controls cannot not meet criteria for MDD and their CDRS-R raw score must be below 28; T-score < 52).

Exclusion Criteria:

• Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis NOS;
• current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, OCD, or autism-spectrum disorders;
• taking psychotropic medications prior to entry;
• estimated IQ < 80; alcohol/drug dependence or abuse within the last 3 months;
• potential/confirmed neurological disorder or epilepsy;
• claustrophobia;
• presence of a medical condition that precludes fMRI;
• endorsement of imminent and serious suicidality;
• medical conditions that take precedence over the presence of MDD;
• pregnancy;
• substance use (excluding nicotine) within two weeks of the fMRI scan;
• left-handedness;
• nicotine use within 3 hours of the fMRI scan;
• history of traumatic brain injury or of being unconscious for more than 30 minutes;
• a stimulant regime for ADHD which has changed within 30 days of the fMRI scan.
• Non-compliance (i.e. <70% completion) or inability (i.e. lack of smartphone device) to complete the 3 assessment periods of EMA.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MDD patients; Participants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment.

Behavioral: Behavioral Activation Therapy; Participants will be seen for a maximum of 16 sessions of therapy focused on increasing rewarding behaviors (16 individual therapy sessions of 1-hour, 2 of which include the BSIS component) over 16 weeks. BA intervention includes monthly booster sessions offered throughout 6-month follow up. If needed, two extra sessions will be allowed during treatment.; Other Names: BA Therapy; Behavioral: Baseline assessment procedures; Completion of the K-SADS and CDRS-R to assess MDD, and the Wechsler Abbreviated Scale of Intelligence - 2nd Edition to assess IQ.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diagnostic Interview Status (CDRS-R) total score from baseline	Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. Following on prior studies of adolescent MDD, a diagnosis of MDD and a CDRS-R score of 45 or greater is the criterion for admission to the study. A score of 27 or less at the end of the study is the criterion for remission of MDD.	Baseline, week 16 post intervention
Change in Adolescent Longitudinal Interval Follow-Up Evaluation (A-LIFE)	The A-LIFE Interview, developed for use with adolescents, was based on the Longitudinal Interval Follow-up Evaluation scale (LIFE), a clinical interview for adults. The A-LIFE comprises three general sections, including psychopathology, psychosocial functioning, and general severity of the disorder (GSD). The psychopathology domain will be used in the current study because it provides information regarding whether the participant has met the criteria and symptoms of DSM-5 disorders. The A-LIFE measure of greatest interest in the current study is the 6-point rating of each identified psychiatric disorder. Each form of psychopathology is scored 1-6, and a depression score of 4, 5, or 6 yields a positive diagnosis of MDD. The primary outcome variable will be the number of MDD patients reaching remission status (<4).	Week 8 post intervention (Midpoint), week 16 post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Beck Depression Inventory (BDI-II)	BDI-II is a 21-self report assessment of the level of depressive symptoms over 2-week period. The minimum and maximum values for the BDI-II are (0-63). The higher the scores, the greater the severity of depression.	Baseline, weekly therapy visits 1-16 post intervention

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Michael Treadway, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Behavioral Activation; fMRI
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: IRB00078545; 1R01MH126985-01A1 (U.S. NIH Grant/Contract); 2025P011729 (Other Identifier: Emory IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data (including access and additional documents) will be shared through the NIMH NDA and in accordance with NIMH NDA data-sharing policy.
• IPD Sharing Time Frame: As soon as possible after data collection.
• IPD Sharing Access Criteria: In accordance with NIMH NDA data-sharing policy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No